TY - JOUR
T1 - Rituximab-chop with early rituximab intensification for diffuse large b-cell lymphoma
T2 - A randomized phase iii trial of the hovon and the nordic lymphoma group (hovon-84)
AU - Lugtenburg, Pieternella Johanna
AU - De Nully Brown, Peter
AU - Van der Holt, Bronno
AU - D'Amore, Francesco A.
AU - Koene, Harry R.
AU - De Jongh, Eva
AU - Fijnheer, Rob
AU - Van Esser, Joost W.
AU - Bohmer, Lara H.
AU - Pruijt, Johannes F.
AU - Verhoef, Gregor E.
AU - Hoogendoorn, Mels
AU - Bilgin, Memis Y.
AU - Nijland, Marcel
AU - Van der Burg-De Graauw, Nicole C.
AU - Oosterveld, Margreet
AU - Jie, Kon Siong G.
AU - Larsen, Thomas Stauffer
AU - Van der Poel, Marjolein W.
AU - Leijs, Maria B.
AU - Silbermann, Matthijs H.
AU - Van Marwijk Kooy, Marinus
AU - Beeker, Aart
AU - Kersten, Marie J.
AU - Doorduijn, Jeanette K.
AU - Tick, Lidwine W.
AU - Brouwer, Rolf E.
AU - Lam, King H.
AU - Burggraaff, Coreline N.
AU - De Keizer, Bart
AU - Arens, Anne I.
AU - De Jong, Daphne
AU - Hoekstra, Otto S.
AU - Zijlstra-Baalbergen, Josee M.
N1 - Funding Information:
The funding sources had no role in design, data collection, data analysis, or interpretation of the findings. Supported by Grant No. CKTO 2006-14 from the Dutch Cancer Society, which funded clinical data management, and by Roche Nederland, which funded the pharmacokinetic and clinical studies and supplied the off-label rituximab.
Publisher Copyright:
© 2020 by American Society of Clinical Oncology.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/10/10
Y1 - 2020/10/10
N2 - PURPOSE: Immunochemotherapy with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) has become standard of care for patients with diffuse large B-cell lymphoma (DLBCL). This randomized trial assessed whether rituximab intensification during the first 4 cycles of R-CHOP could improve the outcome of these patients compared with standard R-CHOP.PATIENTS AND METHODS: A total of 574 patients with DLBCL age 18 to 80 years were randomly assigned to induction therapy with 6 or 8 cycles of R-CHOP-14 with (RR-CHOP-14) or without (R-CHOP-14) intensification of rituximab in the first 4 cycles. The primary end point was complete remission (CR) on induction. Analyses were performed by intention to treat.RESULTS: CR was achieved in 254 (89%) of 286 patients in the R-CHOP-14 arm and 249 (86%) of 288 patients in the RR-CHOP-14 arm (hazard ratio [HR], 0.82; 95% CI, 0.50 to 1.36;
P = .44). After a median follow-up of 92 months (range, 1-131 months), 3-year failure-free survival was 74% (95% CI, 68% to 78%) in the R-CHOP-14 arm versus 69% (95% CI, 63% to 74%) in the RR-CHOP-14 arm (HR, 1.26; 95% CI, 0.98 to 1.61;
P = .07). Progression-free survival at 3 years was 74% (95% CI, 69% to 79%) in the R-CHOP-14 arm versus 71% (95% CI, 66% to 76%) in the RR-CHOP-14 arm (HR, 1.20; 95% CI, 0.94 to 1.55;
P = .15). Overall survival at 3 years was 81% (95% CI, 76% to 85%) in the R-CHOP-14 arm versus 76% (95% CI, 70% to 80%) in the RR-CHOP-14 arm (HR, 1.27; 95% CI, 0.97 to 1.67;
P = .09). Patients between ages 66 and 80 years experienced significantly more toxicity during the first 4 cycles in the RR-CHOP-14 arm, especially neutropenia and infections.
CONCLUSION: Early rituximab intensification during R-CHOP-14 does not improve outcome in patients with untreated DLBCL.
AB - PURPOSE: Immunochemotherapy with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) has become standard of care for patients with diffuse large B-cell lymphoma (DLBCL). This randomized trial assessed whether rituximab intensification during the first 4 cycles of R-CHOP could improve the outcome of these patients compared with standard R-CHOP.PATIENTS AND METHODS: A total of 574 patients with DLBCL age 18 to 80 years were randomly assigned to induction therapy with 6 or 8 cycles of R-CHOP-14 with (RR-CHOP-14) or without (R-CHOP-14) intensification of rituximab in the first 4 cycles. The primary end point was complete remission (CR) on induction. Analyses were performed by intention to treat.RESULTS: CR was achieved in 254 (89%) of 286 patients in the R-CHOP-14 arm and 249 (86%) of 288 patients in the RR-CHOP-14 arm (hazard ratio [HR], 0.82; 95% CI, 0.50 to 1.36;
P = .44). After a median follow-up of 92 months (range, 1-131 months), 3-year failure-free survival was 74% (95% CI, 68% to 78%) in the R-CHOP-14 arm versus 69% (95% CI, 63% to 74%) in the RR-CHOP-14 arm (HR, 1.26; 95% CI, 0.98 to 1.61;
P = .07). Progression-free survival at 3 years was 74% (95% CI, 69% to 79%) in the R-CHOP-14 arm versus 71% (95% CI, 66% to 76%) in the RR-CHOP-14 arm (HR, 1.20; 95% CI, 0.94 to 1.55;
P = .15). Overall survival at 3 years was 81% (95% CI, 76% to 85%) in the R-CHOP-14 arm versus 76% (95% CI, 70% to 80%) in the RR-CHOP-14 arm (HR, 1.27; 95% CI, 0.97 to 1.67;
P = .09). Patients between ages 66 and 80 years experienced significantly more toxicity during the first 4 cycles in the RR-CHOP-14 arm, especially neutropenia and infections.
CONCLUSION: Early rituximab intensification during R-CHOP-14 does not improve outcome in patients with untreated DLBCL.
UR - http://www.scopus.com/inward/record.url?scp=85092749826&partnerID=8YFLogxK
U2 - 10.1200/JCO.19.03418
DO - 10.1200/JCO.19.03418
M3 - Article
C2 - 32730183
AN - SCOPUS:85092749826
SN - 0732-183X
VL - 38
SP - 3377
EP - 3387
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 29
ER -